Rule2022-25219
Schedules of Controlled Substances: Placement of Mesocarb in Schedule I
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 22, 2022
Effective
December 22, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
With the issuance of this final rule, the Drug Enforcement Administration places mesocarb (chemical name: N-phenyl-N' -(3-(1- phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium-5-yl)carbamimidate), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle mesocarb.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 224 (Tuesday, November 22, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Rules and Regulations]
[Pages 71247-71250]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25219]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-397]
Schedules of Controlled Substances: Placement of Mesocarb in
Schedule I
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: With the issuance of this final rule, the Drug Enforcement
Administration places mesocarb (chemical name: N-phenyl-N' -(3-(1-
phenylpropan-2-yl)-1,2,3-oxadiazol-3-ium-5-yl)carbamimidate), including
its salts, isomers, and salts of isomers, in schedule I of the
Controlled Substances Act. This action is being taken to enable the
United States to meet its obligations under the 1971 Convention on
Psychotropic Substances. This action imposes the regulatory controls
and administrative, civil, and criminal sanctions applicable to
schedule I controlled substances on persons who handle (manufacture,
distribute, import, export, engage in research, conduct instructional
activities or chemical analysis with, or possess), or propose to handle
mesocarb.
DATES: Effective date: December 22, 2022.
FOR FURTHER INFORMATION CONTACT: Dr. Terrence L. Boos, Drug and
Chemical Evaluation Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 362-3249.
SUPPLEMENTARY INFORMATION:
Legal Authority
The United States is a party to the 1971 United Nations Convention
on Psychotropic Substances (1971 Convention), February 21, 1971, 32
U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting
changes in drug schedules under the 1971 Convention are governed
domestically by 21 U.S.C. 811(d)(2)--(4). When the United States
receives notification of a scheduling decision pursuant to Article 2 of
the 1971 Convention adding a drug or other substance to a specific
schedule, the Secretary of the Department of Health and Human Services
(HHS),\1\ after consultation with the Attorney General, shall first
determine whether existing legal controls under subchapter I of the
Controlled Substances Act (CSA) and the Federal Food, Drug, and
Cosmetic Act meet the requirements of the schedule specified in the
notification with respect to the specific drug or substance.\2\ Based
on those determinations, as appropriate, the Secretary of HHS
(Secretary) shall recommend to the Attorney General that he initiate
proceedings for scheduling the drug or substance pursuant to 21 U.S.C.
811(a) and (b).\3\ The CSA also
[[Page 71248]]
stipulates that in certain circumstances where the permanent section
811(a) scheduling will not be completed in time as required by the 1971
Convention, the Attorney General shall, after satisfying other
specified conditions, issue a temporary order controlling the drug or
substance under schedule IV or V, whichever is most appropriate to
carry out the minimum United States obligations under the 1971
Convention.\4\
---------------------------------------------------------------------------
\1\ As discussed in a memorandum of understanding entered into
by the Food and Drug Administration (FDA) and the National Institute
on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in
carrying out the Secretary's scheduling responsibilities under the
CSA, with the concurrence of NIDA. 50 FR 9518 (March 8, 1985). The
Secretary of HHS has delegated to the Assistant Secretary for Health
of HHS the authority to make domestic drug scheduling
recommendations. 58 FR 35460 (July 1, 1993).
\2\ 21 U.S.C. 811(d)(3).
\3\ Id.
\4\ 21 U.S.C. 811(d)(4)(A).
---------------------------------------------------------------------------
In the event that the Secretary did not so consult with the
Attorney General to make a determination about the existing legal
controls, and the Attorney General did not issue a temporary order, the
procedures for permanent scheduling are set forth in 21 U.S.C. 811(a)
and (b). Pursuant to 21 U.S.C. 811(a)(1), the Attorney General may, by
rule, add to such a schedule or transfer between such schedules any
drug or other substance, if he finds that such drug or other substance
has a potential for abuse, and makes with respect to such drug or other
substance the findings prescribed by 21 U.S.C. 812(b) for the schedule
in which such drug or other substance is to be placed. The Attorney
General has delegated this scheduling authority to the Administrator of
the Drug Enforcement Administration (Administrator).\5\
---------------------------------------------------------------------------
\5\ 28 CFR 0.100.
---------------------------------------------------------------------------
Background
Mesocarb (chemical name: N-phenyl-N' -(3-(1-phenylpropan-2-yl)-
1,2,3-oxadiazol-3-ium-5-yl)carbamimidate) is a central nervous system
(CNS) stimulant.
At its 38th session (March 1995), the United Nations Commission on
Narcotic Drugs added mesocarb to Schedule IV of the 1971 Convention,
thus notifying all parties to the 1971 Convention.
DEA and HHS Eight Factor Analyses
On April 3, 2012, in accordance with 21 U.S.C. 811(b), and in
response to the Drug Enforcement Administration's (DEA) August 12, 2008
request, HHS provided to DEA a scientific and medical evaluation and a
scheduling recommendation for mesocarb. DEA subsequently reviewed HHS'
evaluation and recommendation for schedule I placement and all other
relevant data and conducted its own analysis under the eight factors
stipulated in 21 U.S.C. 811(c). DEA found, under 21 U.S.C. 812(b)(1),
that this substance warrants control in schedule I. Both DEA and HHS
analyses are available in their entirety under ``Supporting and Related
Material'' of the public docket for this rule at <a href="https://www.regulations.gov">https://www.regulations.gov</a> under docket number DEA-397.
Notice of Proposed Rulemaking To Schedule Mesocarb
On August 11, 2021, DEA published a notice of proposed rulemaking
(NPRM) entitled ``Schedules of Controlled Substances: Placement of
mesocarb in schedule I.'' \6\ The NPRM provided an opportunity for
interested persons to file a request for a hearing in accordance with
DEA regulations on or before September 10, 2021. No requests for such a
hearing were received by DEA. The NPRM also provided an opportunity for
interested persons to submit comments on the proposed rule on or before
October 12, 2021.
---------------------------------------------------------------------------
\6\ 86 FR 43978.
---------------------------------------------------------------------------
Comments Received
DEA received two comments on the proposed rule to control mesocarb
in schedule I of the CSA.
Support for rulemaking: One commenter supported the placement of
mesocarb in schedule I due to the continued abuse of controlled
substances.
DEA Response: DEA appreciates the comment in support of this
rulemaking.
Opposition to rulemaking: One commenter opposed the placement of
mesocarb in schedule I by suggesting it be placed in schedule II due to
the infrequent use in the United States and its availability and use in
other countries.
DEA Response: DEA does not agree. DEA is not aware of any
availability or source of mesocarb in the United States, and the
commenter did not provide any evidence of its use in the United States.
As discussed in HHS's eight-factor analysis, mesocarb is not approved
by the United States Food and Drug Administration (FDA) for use in the
United States. As explained in the NPRM, the medical and scientific
evaluation and scheduling recommendation issued by the Assistant
Secretary for Health of HHS (Assistant Secretary) concludes that
mesocarb has no currently accepted medical use in treatment in the
United States and lacks accepted safety for use under medical
supervision.
In addition, DEA conducted an eight-factor analysis pursuant to 21
U.S.C. 811(c), and based its scheduling determination on a
comprehensive evaluation of all available data. As stated in the NPRM,
after careful review of all data, DEA concurred with HHS' assessment
that mesocarb has a high potential for abuse with no currently accepted
medical use in treatment in the United States and lacks accepted safety
for use under medical supervision. Congress established only one
schedule, schedule I, for drugs of abuse with ``no currently accepted
medical use in treatment in the United States'' and ``lack of accepted
safety for use under medical supervision.'' \7\ The other four
schedules require the drug or other substance to have a currently
accepted medical use in treatment in the United States or a currently
accepted medical use with severe restrictions (schedule II) or a
currently accepted medical use in treatment in the United States
(schedules III through V).\8\ DEA is therefore promulgating this final
rule placing mesocarb in schedule I under the CSA.
---------------------------------------------------------------------------
\7\ 21 U.S.C. 812(b).
\8\ Id.
---------------------------------------------------------------------------
Scheduling Conclusion
After consideration of the public comments, the scientific and
medical evaluation and accompanying recommendation of HHS, and
conducting an independent eight-factor analysis, DEA finds substantial
evidence of potential for abuse of mesocarb. As such, DEA is
permanently scheduling mesocarb as a controlled substance under the
CSA.
Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as schedules I, II, III, IV, and V.\9\ The CSA also outlines the
findings required to place a drug or other substance in any particular
schedule.\10\ After consideration of the analysis and recommendation of
the Assistant Secretary and review of all other available data, the
Administrator, pursuant to 21 U.S.C. 811(a) and 812(b)(1), finds that:
---------------------------------------------------------------------------
\9\ 21 U.S.C. 812(a).
\10\ 21 U.S.C. 812(b).
---------------------------------------------------------------------------
(1) Mesocarb has a high potential for abuse. This potential is
comparable to certain schedule II substances (e.g., methamphetamine or
amphetamine);
(2) Mesocarb has no currently accepted medical use in treatment in
the United States; \11\ and
---------------------------------------------------------------------------
\11\ Although there is no evidence suggesting that mesocarb has
a currently accepted medical use in treatment in the United States,
it bears noting that a drug cannot be found to have such medical use
unless DEA concludes that it satisfies a five-part test.
Specifically, with respect to a drug that has not been approved by
FDA, to have a currently accepted medical use in treatment in the
United States, all of the following must be demonstrated: i. the
drug's chemistry must be known and reproducible; ii. there must be
adequate safety studies; iii. there must be adequate and well-
controlled studies proving efficacy; iv. the drug must be accepted
by qualified experts; and v. the scientific evidence must be widely
available. 57 FR 10499 (1992), pet. for rev. denied, Alliance for
Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 (D.C. Cir. 1994).
---------------------------------------------------------------------------
[[Page 71249]]
(3) There is a lack of accepted safety for use of mesocarb under
medical supervision.
Based on these findings, the Administrator concludes that mesocarb,
including its salts, isomers, and salts of isomers, warrants control in
schedule I of the CSA.\12\
---------------------------------------------------------------------------
\12\ 21 U.S.C. 812(b)(1).
---------------------------------------------------------------------------
Requirements for Handling Mesocarb
Effective as of December 22, 2022, mesocarb will be subject to the
CSA's schedule I regulatory controls and administrative, civil, and
criminal sanctions applicable to the manufacture, distribution,
dispensing, importing, exporting, research, and conduct of
instructional activities, including the following:
1. Registration. Any person who handles (manufactures, distributes,
imports, exports, engages in research, or conducts instructional
activities or chemical analysis with, or possesses) mesocarb, or who
desires to handle mesocarb, must be registered with DEA to conduct such
activities pursuant to 21 U.S.C. 822, 823, 957, and 958, and in
accordance with 21 CFR parts 1301 and 1312. Any person who handles
mesocarb and is not registered with DEA must submit an application for
registration and may not continue to handle mesocarb after the
effective date of this rule, unless DEA has approved that application,
pursuant to 21 U.S.C. 822, 823, 957, and 958 and in accordance with 21
CFR parts 1301 and 1312.
2. Disposal of stocks. Any person unwilling or unable to obtain a
schedule I registration must surrender all quantities of mesocarb as of
the effective date of this rule, or may transfer all such quantities of
mesocarb to a person registered with DEA. Mesocarb is required to be
disposed of in accordance with 21 CFR part 1317, in addition to all
other applicable Federal, State, local, and tribal laws.
3. Security. Mesocarb is subject to schedule I security
requirements and must be handled and stored pursuant to 21 U.S.C. 821
and 823 and in accordance with 21 CFR parts 1301.71-1301.76. Non-
practitioners handling mesocarb must also comply with the employee
screening requirements of 21 CFR parts 1301.90-1301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of mesocarb must comply with 21 U.S.C. 825 and be
in accordance with 21 CFR part 1302.
5. Quota. Only registered manufacturers are permitted to
manufacture mesocarb in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21 CFR part 1303.
6. Inventory. Every DEA registrant who possesses any quantity of
mesocarb must take an inventory of mesocarb on hand pursuant to 21
U.S.C. 827, and in accordance with 21 CFR parts 1304.03, 1304.04, and
1304.11(a) and (d).
Any person who registers with DEA must take an initial inventory of
all stocks of controlled substances (including mesocarb) on hand on the
date the registrant first engages in the handling of controlled
substances, pursuant to 21 U.S.C. 827, 958, and in accordance with 21
CFR parts 1304.03, 1304.04, and 1304.11(a) and (b).
After the initial inventory, every DEA registrant must take an
inventory of all controlled substances (including mesocarb) on hand
every two years, pursuant to 21 U.S.C. 827, and in accordance with 21
CFR parts 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant must maintain records
and submit reports with respect to mesocarb, pursuant to 21 U.S.C. 827,
and in accordance with 21 CFR 1301.74(b) and (c) and 1301.76(b), and
parts 1304, 1312, and 1317. Manufacturers and distributors must submit
reports regarding mesocarb to the Automation of Reports and
Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance
with 21 CFR parts 1304 and 1312.
8. Order Forms. Every DEA registrant who distributes or orders
mesocarb must comply with the order form requirements, pursuant to 21
U.S.C. 828 and in accordance with 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of
mesocarb must comply with 21 U.S.C. 952, 953, 957, and 958, and in
accordance with 21 CFR part 1312.
10. Liability. Any activity involving mesocarb not authorized by,
or in violation of, the CSA or its implementing regulations, is
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review) and 13563
(Improving Regulation and Regulatory Review)
In accordance with 21 U.S.C. 811(a), this final scheduling action
is subject to formal rulemaking procedures performed ``on the record
after opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for
scheduling a drug or other substance. Such actions are exempt from
review by the Office of Management and Budget (OMB) pursuant to section
3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed
in E.O. 13563.
Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the States, on the relationship between the National
Government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It does not have substantial direct effects
on one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 601-612, has reviewed this final rule and by approving it
certifies that it will not have a significant economic impact on a
substantial number of small entities.
DEA is placing the substance mesocarb, including its salts,
isomers, and salts of isomers, in schedule I of the CSA. This action is
being taken to enable the United States to meet its obligations under
the 1971 Convention. This action imposes the regulatory controls and
administrative, civil, and criminal sanctions applicable to schedule I
controlled substances on persons who handle (manufacture, distribute,
reverse distribute, import, export, engage in research, conduct
instructional activities or chemical
[[Page 71250]]
analysis with, or possess) mesocarb, or propose to handle mesocarb.
Based on the review of HHS' scientific and medical evaluation and
all other relevant data, DEA determined that mesocarb has a high
potential for abuse, has no currently accepted medical use in treatment
in the United States, and lacks accepted safety for use under medical
supervision. DEA's research confirms that there is no legitimate
commercial market for mesocarb in the United States. Therefore, DEA
estimates that no United States entity currently handles mesocarb and
does not expect any United States entity to handle mesocarb in the
foreseeable future. DEA concludes that no legitimate United States
entity would be affected by this rule. As such, this rule will not have
a significant effect on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined and certifies that this
action would not result in any Federal mandate that may result ``in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any 1 year * * *.'' Therefore, neither a Small
Government Agency Plan nor any other action is required under UMRA of
1995.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, DEA is
submitting a copy of this final rule to both Houses of Congress and to
the Comptroller General.
Signing Authority
This document of the Drug Enforcement Administration was signed on
November 14, 2022, by Administrator Anne Milgram. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is amended as
follows:
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
1. The authority citation for 21 CFR part 1308 continues to read as
follows:
Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise
noted.
0
2. Amend Sec. 1308.11 by redesignating paragraphs (f)(7) through (10)
as paragraphs (f)(8) through (11) and adding a new paragraph (f)(7) to
read as follows:
Sec. 1308.11 Schedule I.
* * * * *
(f) * * *
(7) Mesocarb (N-phenyl-N '-(3-(1-phenylpropan-2-yl)- 1227
1,2,3-oxadiazol-3-ium-5-yl)carbamimidate)..............
* * * * *
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-25219 Filed 11-21-22; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on November 22, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.